KUALA LUMPUR: University and private hospitals will soon have access to more affordable Hepatitis C treatment now that the registration of the first Hepatitis C generic drug under voluntary licensing (VL) has been approved.

Currently, the drug is only available in the Health Ministry’s government hospitals, made possible after the government applied the compulsory licence (CL) of the World Trade Organisation’s Agreement on Trade-Related Aspects of Intellectual Property Rights in September 2017 to gain access to the affordable drug.

(CL are issued for the import or local production of generic drugs. It can be issued by the government or a private company. In government-use CL, the product is to be for public, non-commercial use.)

The National Pharmaceutical Regulatory Agency approved the generic version of the sofosbuvir on March 7.

University Malaya Medical Centre consultant hepatologist Prof Dr Rosmawati Mohamed said with the direct-acting antivirals (DAAs) available through VL, Malaysians can truly have nationwide access, including university hospitals and private hospitals, and the burden of treatment could be shared.

“But it is equally important to have approval from more companies soon as competition can lower prices,” she said.

Positive Malaysian Treatment Access and Advocacy Group (MTAAG+) congratulated the Health Ministry on the approval.

Its director Edward Low said the drug was the backbone combination that treats all types of Hepatitis C (pangenotyping), with little or no side effect.

“With this positive move, MTAAG+ would like to strongly urge Malaysians to go for Hepatitis C screening and to those who have been diagnosed to continue getting treatment,” he said.

Low said that screening needed to be scaled up to achieve the World Health Organisation’s goal of Hepatitis C elimination by 2030.

Prof Rosmawati said with only 1,500 patients treated since the drug combination, generic sofosbuvir and daclatasvir, was made available in public hospitals in March last year, it would be difficult for Malaysia to reach the elimination target by 2030.

“We have diagnosed less than 10% of the estimated number of those with active infection. We need to ‘find the missing thousands’ who are unaware that they are infected,” she said.

She said 5,000 Hepatitis C patients should have been treated last year and 10,000 this year.

“There is a need to immediately scale up diagnosis and treatment if we are to achieve the elimination target, which the Health Ministry had started,” she said.

On 1 February 2019, Italy submitted a draft resolution on transparency to the World Health Organization (WHO). This resolution is to be discussed in May 2019, at the 72nd session of the World Health Assembly (WHA).

The title of the proposed resolution is “Improving the transparency of markets for drugs,
vaccines and other health-related technologies,” and it sets out a number of measures
designed to achieve this objective .

There are deplorable asymmetries of access to information about many aspects of the
innovation and supply chain for medicines, vaccines and other health technologies. The lack of information creates confusion about basic facts related to prices, research and
development costs and other aspects of the value chain for medicines, vaccines and health technologies.

The resolution would create a work program for the WHO and norms for governments to cooperate in improving the transparency of various aspects of these technologies.

This is a critical time for governments to consider reforms in pricing and incentives for
innovation for health technologies. The transparency measures proposed in the resolution will ensure that consideration of such reforms will be based upon the best possible evidence.

With much appreciation we would like to congratulate the Ministry of Health Malaysia on the approval of marketing the first affordable generic Direct Acting Antivirals (DAAs) also known as Sofosbuvir on 7th March, 2019.

This is the backbone combination to treat all type of Hepatitis C (pangenotyping) which has little or no side effect compared to the previous medication regime using Interferon (IFN).

As such, we would like to encourage people at risk and people that have been diagnosed to come forward and do the needful. We believe that in scaling up the screening in addition to treatment is a big leap initiative to achieve the goal of Hepatitis C elimination by 2030.

With this very positive move, Positive Malaysian Treatment Access and Advocacy Group (MTAAG+) would like to strongly urges Malaysians to go for Hepatitis C screening and to those who have been diagnosed to continue getting treatment at any of 26 government hospitals nationwide.

Price gouging in the pharmaceutical industry has become a common feature of health news. Who can forget Martin Shkreli’s infamous price hike of the HIV drug Daraprim, which went from USD13.50 to $750 in the summer of 2015? Are international laws tough enough to ensure that the bottom line is the people and not profit?Produced by: Tina Carmillia

Across the United States, about 1 of every 7 individuals in jail or prison has chronic hepatitis C. In some states, such as New Mexico, it’s closer to 1 in 3. With approximately 9 million people spending time in prison or jail over the course of a year, more than 1.2 million incarcerated individuals have chronic hepatitis C.

Left untreated, this viral disease can cause serious and costly health problems, including cirrhosis, liver cancer, liver failure, and even death. Once a difficult-to-treat infection, chronic hepatitis C can now be cured by taking a regimen of daily pills for eight to 12 weeks that act directly against the virus. But there’s a hitch: This cure costs $25,000 or more per person.

Although treating every incarcerated individual with chronic hepatitis C is the right thing to do for several reasons (more on that in a minute), doing it would exceed the health care budgets of jail and prison systems.

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We believe there’s a solution that won’t break the bank. It’s called nominal pricing. This pricing mechanism provides deep discounts of at least 90 percent on drugs to so-called safety-net facilities. (By law, the nominal price of a drug must be less than 10 percent of its average market price.) These include hospitals and clinics that treat many patients without insurance or who are homeless. Because of the high markup on hepatitis C drugs, a nominal price is still well above the cost to manufacture the pills.

Nominal pricing permits manufacturers to sell drugs to safety-net facilities at a low price without disrupting the Medicaid market. Offering a discount to one customer usually triggers a similar discount on any drugs sold in the Medicaid program. Nominal pricing provides a way to prevent this from happening, and so can entice drug manufacturers into offering substantially lower prices to safety-net facilities that otherwise may not be able to afford certain drugs.

As we and colleagues from Brown University, the Alaska Department of Corrections, and the law firm of Powers, Pyles, Sutter, and Verville wrote in the Journal of Correctional Health Care, extending nominal pricing to correctional facilities could drastically cut the cost to cure hepatitis C in prisons and jails.

When we first drafted a strategy to use nominal pricing in prisons in 2017, Gilead Sciences’ hepatitis C treatment ledipasvir/sofosbuvir (Harvoni) cost about $70,000 per patient course. Other companies had similar prices for their hepatitis drugs. Since then, drug manufacturers have reduced the price of a full course of treatment to below $25,000. Even at that price, however, the cost of treating all inmates isn’t affordable without making deep cuts elsewhere, such as in prison drug treatment programs, which would be a counterproductive move.

Not all incarcerated individuals with hepatitis C stay long enough in prison or jail to complete the eight-to-12-week course of treatment. At the current price, treating approximately 10 percent of them would cost $3.3 billion. At the nominal pricing discount, the cost would be $337.5 million, saving U.S. taxpayers approximately $3 billion.

Prisons and jails represent an untapped market for drug company sales. Nominal pricing is a strategy that can close the gap between treatment demand and supply. With nominal pricing, companies can sell their hepatitis C drugs above the production price and still make a profit.

Researchers at UT Southwestern Medical Center studied the records of patients who had been successfully treated for liver cancer at 31 medical centers in North America, comparing those who were and were not given direct-acting antivirals for hepatitis C. The study found no significant difference in the recurrence of liver cancer between the two groups.

Similarly, the study found no difference in the aggressiveness of the cancer in those patients who did experience a recurrence.

“Our study was inspired by a single-center study from Spanish investigators in 2016. That study gained a lot of press and sparked fear about treating liver cancer patients for their hepatitis C,” said Dr. Amit Singal, Associate Professor of Internal Medicine and Medical Director of the Liver Tumor Program. “Based on these new data, providers can feel reassured that it is safe to treat hepatitis C in these patients and allow them to receive the known benefits of hepatitis C therapy.”

Some 3.2 million individuals in the U.S., the large majority of them baby boomers, have chronic hepatitis C infection. Many of these individuals struggle with inflammation of the liver and impaired liver function, as well as cirrhosis, or scarring of liver tissue. Since 2013, effective antiviral drugs have been available to treat hepatitis C infection.

Chronic hepatitis C infection is also one of the leading causes of liver cancer. According to the Centers for Disease Control and Prevention, half of all individuals with liver cancer have underlying chronic hepatitis C infection.

The rate of new cases of liver cancer has been rising steadily in recent decades, and the state of Texas has one of the highest rates of occurrence in the country.

When liver cancer is diagnosed early, it can be effectively treated with surgery, ablation, or radiation therapy. Sometimes liver cancer patients have their tumor successfully removed, but the underlying chronic hepatitis C infection remains and continues to impair liver function further.

In this study, published in the journal Gastroenterology, 42 percent of liver cancer survivors who were treated with direct-acting antivirals (DAAs) experienced a recurrence of their cancer, compared with 59 percent of patients who were not treated with antivirals.

“Our results suggest that use of DAA therapies is safe and potentially beneficial in hepatitis C-infected patients with a history of liver cancer,” said Dr. Singal, who holds the David Bruton, Jr. Professorship in Clinical Cancer Research and is Clinical Chief of Hepatology.

Other UT Southwestern faculty members who contributed to the study are Dr. Nicole E. Rich, Assistant Professor of Internal Medicine, and Dr. Caitlin Murphy, Assistant Professor of Clinical Sciences.

Funding for this study was provided by the National Cancer Institute and AbbVie Inc. Dr. Singal has served on advisory boards and has received funding from Gilead and AbbVie. He has previously participated in a speakers’ bureau for Gilead. Other disclosures unrelated to this research appear in Gastroenterology.

About UT Southwestern Medical Center

UT Southwestern, one of the premier academic medical centers in the nation, integrates pioneering biomedical research with exceptional clinical care and education. The institution’s faculty has received six Nobel Prizes, and includes 22 members of the National Academy of Sciences, 17 members of the National Academy of Medicine, and 15 Howard Hughes Medical Institute Investigators. The faculty of more than 2,700 is responsible for groundbreaking medical advances and is committed to translating science-driven research quickly to new clinical treatments. UT Southwestern physicians provide care in about 80 specialties to more than 105,000 hospitalized patients, nearly 370,000 emergency room cases, and oversee approximately 2.4 million outpatient visits a year.

A pharmacist collects packets of boxed medication from the shelves of a pharmacy in London, Britain. In general, Malaysians dont seem to be getting the best prices for their medicines as many of them are marked up, according to a survey. — Bloomberg

The attainment of universal health coverage is premised on affordable medicines and other cost-effective medical technologies.

An affordable price is one that can reasonably be funded by health budgets and/or out-of-pocket (OOP) by individuals.

The price of a medicine is influenced by the market. It includes the price paid to the manufacturer, price paid by the purchaser, prices from suppliers and prices paid to third parties like tendering agents.

A patented medicine usually has a high price until the patent expires, and competition and/or generics materialise.

The prices of generics after the patent expires are much less than the original patented drug and usually decrease with time.

Prescription medicines comprised about a third of private household OOP healthcare expenditure in Malaysia. The OOP expenditure in 2014 was 39.3% of total health expenditure.

The Health Ministry’s budgetary allocation for medicines in 2018 was RM4.1 billion (15.43% of total budget of RM26.58 billion), which was the same as in 2017.

The budgetary allocation for medicines and service upgrades in 2019 is RM10.8 billion (total budget of RM28.7 billion). Time will tell how much of this allocation will be utilised by the former.

The World Health Organization (WHO) defines essential medicines as “those that satisfy the priority health care needs of the population”.

They are selected with “due regard to public health relevance, evidence on efficacy and safety, and comparative cost-effectiveness”.

Drugs on essential medicines lists “are intended to be available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality and adequate information, and at a price the individual and the community can afford”.

The Health Ministry has an essential medicine list called the National Essential Medicine List (NEML).

Public sector prices

The International Reference Pricing (IRP) is the process of cost comparison through external reference or cross-reference, i.e. using the price of a medicine (generally ex-manufacturer price, or other common point within the distribution chain) in one or several countries to derive a benchmark or reference price for the purposes of setting or negotiating the price of the product in a given country.

As a very substantial purchaser of medicines, it would be expected that the Health Ministry would be able to procure medicines at a lower price than the private sector.

However, the Harvard Study group report to the Health Ministry on the procurement of medicines tells a different story.

“In Malaysia, public sector procurement prices were on average three to four times the corresponding IRP for the period 2010–2014 when purchases were weighted by total expenditure, and around twice as high as the corresponding IRP when weighted by volume …

“From 2010 to 2014, between 22% (2012) and 30% (2011) of all medicine products were procured at prices below the IRP.

“During the same period, between 45% (2013) and 50% (2012) of medicine products were procured at more than two times the IRP.

“However, in the most recent year (2014), medicines purchased at or below two times the IRP accounted for nearly 80% of medicines by volume, and this share has gradually increased from 2010 for the basket of medicines with an IRP match from 2010 to 2014.

“These medicines, however, accounted for only 55% of total expenditures, indicating that higher procurement prices for high-cost, but low volume, products have a substantial impact on the budget for medicines.

“This is a potential area for improvement in medicines procurement in the public sector.”

Health Minister Dr Dzulkefly Ahmad (right) looks at the medicine received by a patient at the Hospital Kuala Lumpur pharmacy counter during a surprise visit in this filepic, while Health director general Datuk Dr Noor Hisham Abdullah looks on. A report shows that the Health Ministry needs to improve on how it procures medicine, especially in terms of price.

Private sector prices

The affordability of essential medicines in the private sector were reported by researchers from the Health Ministry, who conducted their study annually for two weeks every July from 2011 to 2015.

They reported that the “mark-up of generic medicines was significantly higher than that of innovator medicines during the study period.

“While the mark-up of generic medicine was 31%–402%, that of innovator medicine was 24%–86%.

“There was no significant increase in the median price ratio for 11 selected generic medicines. However, the median price ratio of the 11 innovator medicines significantly increased.

“Affordability of all generic medicines was below the two-day wage for treatment, with captopril (25mg tablet) reporting the highest cost (1.1–1.7-days’ wages).

The Health Ministry’s procurement process for medicines has been in the limelight recently.

The Health Ministry’s statement on its internal investigation on the matter was countered by retorts that claimed that the top six tendering agents collectively were awarded approximately “RM5.93 billion or 92.21% of the approximate RM6.44 billion total tender contracts value”.

The Health Ministry’s statement did not address the value that tendering agents brought to the process and patient care.

Going forward

The inevitable calls for the establishment of an independent body to investigate whether public funds have been spent efficiently and effectively as possible are logical.

Such an independent investigation should include the Health Ministry, which is the end user, as well as the Finance Ministry and other government agencies, whose policies and procedures dictate the procurement process, the prices to be paid for medicines, the role of tendering agents and their value, if any, to patient care.

The objectives should not be limited to the allegations of impropriety, but also to determine the causes of the Health Ministry paying prices higher that IRPs as a result of obsolete policies and/or unfavourable contracts even in the absence of corrupt practices.

When middlemen take a share of the healthcare ringgit, there will be less money for patient care with consequent impacts on safety and quality of care.

Any increase in the prices of medicines will impact negatively on patients’ access to treatment, as health budgets are finite.

There are consequences to a decrease in affordable medicines.

This has led to, and continues to lead to, dissatisfied patients; decreased productivity; increased morbidity and mortality arising from the use of, and change to, different medicines, or to patients foregoing some medicines due to the increased prices; and an inevitable increased burden on public sector healthcare facilities.

The addressing of the issue of affordable medicines will go a long way in the attempt to attain universal healthcare coverage.

Dr Milton Lum is a past president of the Federation of Private Medical Practitioners Associations and the Malaysian Medical Association. The views expressed do not represent that of organisations that the writer is associated with. The information provided is for educational and communication purposes only and it should not be construed as personal medical advice. Information published in this article is not intended to replace, supplant or augment a consultation with a health professional regarding the reader’s own medical care. The Star disclaims all responsibility for any losses, damage to property or personal injury suffered directly or indirectly from reliance on such information.

The committee noted that the prices of patented anti-cancer and antifungal drugs are “on the higher side” and cited the example of Rs 1 lakh being the price for just one injection for cancer treatment.

PTI|

Updated: Jan 27, 2019 ..

In order to cut prices of patented medicines for cancer and rare diseases, a high-level government panel has made a series of far reaching recommendations including granting “compulsory license” to any Indian pharma company to produce drugs without the consent of the patent holding firms.

The report also recommended putting a ceiling price on life-saving medicines after analysing the Purchasing Power Parity (PPP) of various countries, a standard followed in majority of the western world to fix medicine prices.

Multinational pharmaceutical companies sell most of the patented drugs in India and they have been vehemently opposing any sort of price cap or grant of compulsory licensing to any other company to produce drugs being sold by them.

The Indian pharmaceutical market has an annual turnover of around Rs 2.3 lakh crore. While majority of these revenues come from sales of generic drugs, around 30 per cent of it comes from patented drugs.

The committe noted that the prices of patented anti-cancer and antifungal drugs are “on the higher side” and cited the example of Rs 1 lakh being the price for just one injection for cancer treatment.

It said there is a need to moderate the prices of patented anti-diabetic drugs and also recommended that patent owning companies should be “encouraged” to give “voluntary licenses” to other pharmaceutical companies. Moreover, it has stated that the government should explore procurement of more drugs at lower rates for public health care systems through negotiations with pharmaceutical companies.

“The committee after a detailed analysis has come to the conclusion that it is important to put in place an effective mechanism to regulate the prices of patented medicines in India,” the committee’s report stated.

Officials said the government is examining the panel’s report finalised around March last year.

If a company develops an innovative drug, it is granted an intellectual property right for 20 years in the form of a patent. During these 20 years, the patent-owner company can prevent any other company from manufacturing the same medicine, according to existing norms.

Worried about “high prices” and “unaffordability” of patented drugs in India, the Department of Pharmaceuticals (DOP) formed this inter-ministerial committee of Joint Secretaries to “suggest ways and means to fix the prices of patented drugs in the country”

According to a source, the committee submitted its report during February-March last year. However, on January 3 this year, the DOP announced new patented drugs as well as drugs used to treat “rare diseases” would be exempted from price control for a period of five years from the date it is marketed in the country.

Till the January 3 notification, the DOP had the powers to bring patented drugs under price control through powers given under the Drug (Prices Control) Order 2013.

However, the DOP or National Pharmaceutical Pricing Authority (NPPA) rarely used these powers to cap prices of patented drugs.The NPPA works under the DOP only.

“A scientific analysis based on the PPP index of different countries may enable setting a benchmark price for the medicines patented in India,” the committee said.

It added: “Based on the relative PPP index vis-a-vis India, the ex-company sales price in these countries shall be adjusted, and thereafter, the lowest PPP adjusted price anywhere in the world shall be the ceiling price applicable in India. This will ensure that Indian patients get the lowest price in the world for a patented medicine.”

Besides recommending compulsory licensing, the report added that “voluntary licensing arrangements between a patent holder and another party” in a country “may afford opportunities for significant cost-containment and therefore the same may be encouraged”.

The Department of Industrial Policy and Promotion (DIPP), NPPA and the Ministry of Health and Family Welfare were also part of this committee.The Indian Patent Office works under the DIPP.

On November 29 last year, Union Health Secretary Preeti Sudan wrote to the DIPP and the DOP asking them to “bring drugs used for treatment of rare diseases under compulsory licensing s o that their costs become reasonable and affordable to the patients”.

The World Health Orgnaization (WHO) defines “rare disease” as often debilitating lifelong disease or disorder condition with a prevalence of 1 or less, per 1,000 population. Some common rare diseases are Haemophilia, Pompe disease, Thalassemia, Sickle-cell Anaemia and Gaucher’s disease.

KUALA LUMPUR: The government aims to roll out the first tender to start acquiring its first drug through a central pool procurement system in October, an effort that will help bring down the cost of medicines, says Dr Lee Boon Chye (pic).

The Deputy Health Minister said more than 80 types of medicine have been identified for purchase through the system, which combines several buyers into a single entity.

The Health Ministry will partner with the Education Ministry (university hospitals) and the Defence Ministry in the bulk purchase of medicines, he said.

“We are still in discussion with the two ministries. We will also need to get approval from the Finance Ministry.

Pharmaceutical Service Programme senior director Dr Ramli Zainal said they had to look at which tender had expired before they can procure the drugs and see how they could get better prices.
Dr Lee declined to give further details.

World Cancer Day was commemorated on Feb 4 and it was noted that many Malaysians still lack access to affordable treatment.

KUALA LUMPUR: Malaysia has been facing continuous pressure from pharmaceutical companies and their political allies ever since it used compulsory licensing (CL) to gain access to generic versions of a Hepatitis C drug in 2017.

But an international organisation Médecins Sans Frontières (MSF), or known as Doctors Without Borders, has stepped in to support Malaysia’s position.

It has sent a letter addressed to Prime Minister Tun Dr Mahathir Mohamad, Health Minister Datuk Seri Dr Dzulkefly Ahmad and Domestic Trade and Consumer Affairs Minister Datuk Saifuddin Nasution Ismail on Monday (Feb 11), expressing solidarity and support for the Malaysian government as well as urging it to continue to reject any pressure from pharmaceutical corporations and their political allies to reverse the government-use licence.

The letter was also sent to Health director-general Datuk Dr Noor Hisham Abdullah.

“Such pressure violates the integrity and legitimacy of the system of legal rights and flexibilities created by the TRIPs Agreement, as reaffirmed by the Doha Declaration for the World Trade Organisation members to meet their rights and public health obligations,” said MSF Access Campaign executive director Els Torreele in the letter which was uploaded on msfaccess.org website (msfaccess.org/malaysias-compulsory-license-sofosbuvir-positive-step-public-health-and-innovation) late Monday.

“As you are aware, the United Nations Secretary-General’s High-Level Panel on Access to Medicines (HLP) has recognised the problem of access to medicines as a global issue by in 2016.

“As low to high income countries across the globe continue to face significant difficulties with the excessive pricing of medicines by the industry, we commend the Malaysian government’s leadership role in supporting innovation and development of more medicines towards, addressing the HIV and HCV (Hepatitis C virus) epidemics,” she said.

In mid-2016, The Star carried a front-page article about some estimated 400,000 Malaysians infected with Hepatitis C, with most not being able to afford the RM300,000 12-course treatment.

NGOs had called on the government to invoke the CL to gain access to Sofosbuvir.

Direct-acting antiviral medicines (DAAs) such as Sofosbuvir represent a treatment breakthrough for people with chronic Hepatitis C, with cure rates of up to 95% and with far fewer side effects than previous treatments.

Torreele said in many of the countries where MSF worked, MSF was able to provide generic DAAs at $120 (RM489) per 12-week treatment course of Sofosbuvir and Daclatasvir, which were sourced from quality assured generic manufacturers in Egypt and India.

MSF is an independent, international medical humanitarian organisation that provides emergency medical assistance to populations in distress in more than 70 countries.

To make it feasible to treat patients with quality medicines from more affordable and accessible sources, it relied mostly on generic medicines, said Torreele.

Following the adoption of the Doha Declaration on TRIPs and Public Health in 2003, Malaysia became the first country to issue a CL on a medicine to treat HIV and similarly, in 2017, it was the first country to issue a CL for Hepatitis C treatment, she said.

“These decisions illustrate the Malaysian government’s commitment to provide lifesaving medicines to its people,” she said.

Last November, Knowledge Ecology International (keionline.org) reported on its website a 78-page PDF obtained from the United States Trade Representative (USTR) under the Freedom of Information Act on communications between Gilead Sciences, Inc and USTR, over Malaysia’s decision to grant the CL.

NGOs had deemed the move by Gilead using US authorities’ influence to pressure Malaysia to reverse its CL decision as a form of intimidation but Malaysia did not budge.

On Feb 8 this year, the Pharmaceutical Research and Manufacturers of America (PhRMA) had again urged the USTR to “take immediate action to address serious and growing market access and intellectual property barriers in top overseas markets” the markets.businessinsider.com reported.

In its submission for USTR’s annual Special 301 Report, PhRMA called on the Trump administration to name Canada, Japan, Korea and Malaysia as “Priority Foreign Countries” – a designation reserved for countries with the worst market access barriers and the most damaging intellectual property practices.